FORM 10-Q/A
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Amendment to Quarterly Report Under Section 13 or 15(d)
of the Securities Exchange Act of 1934
For Quarter Ended
January 31, 1999 Commission File No. 0-17174
HAUSER, INC.
(formerly Hauser Chemical Research, Inc.)
Colorado 84-0926801
(State or other jurisdiction of
incorporation or organization) (I.R.S. Identification Number)
5555 Airport Boulevard, Boulder, Colorado 80301
(Address of Principal executive offices) (Zip Code)
Registrant's telephone number,
including area code:
(303) 443-4662
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days.
Yes X No
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date.
Common Stock, $.001 par value 10,673,163
Class Outstanding at January 31, 1999
<PAGE>
Part 2.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibit 10.1 Paclitaxel Supply Agreement dated February 3, 1999 (filed
with confidential treatment requested)
Exhibit 10.2 Escrow Agreement dated February 3, 1999 (filed with
confidential treatment requested)
<PAGE>
FORM 10 Q/A
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
HAUSER, INC.
Date: May 11, 1999
/s/ Dean P. Stull
Chairman of the Board, Chief Executive Officer, and
President
Date: May 11, 1999
/s/ David I. Rosenthal
Chief Financial Officer and Treasurer
Exhibit 10.1
CONFIDENTIAL TREATMENT OF REDACTED PORTIONS HAS BEEN GRANTED BY THE SEC
Execution Document
February 3, 1999
Baker Norton Pharmaceuticals Paclitaxel Supply Agreement
THIS SUPPLY AGREEMENT ("Agreement"), dated February 3, 1999, is entered into
by and between BAKER NORTON PHARMACEUTICALS, INC., a Florida corporation
("BNP"), and HAUSER, INC., a Colorado corporation ("Supplier").
WHEREAS, Supplier is a manufacturer of paclitaxel bulk drug substance, has
determined to exit such manufacturing business, has in stock a quantity of
the raw material used to make paclitaxel bulk drug substance, and desires to
use some of such stock to manufacture and supply to BNP paclitaxel bulk drug
substance; and
WHEREAS, BNP desires to have Supplier manufacture and supply paclitaxel bulk
drug substance on and subject to the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the premises and the mutual covenants and
conditions set forth in this Agreement, and other good and valuable
consideration the receipt and sufficiency of which are hereby acknowledged,
the parties agree as follows:
1. Definitions
1.1 Definitions. In addition to terms defined elsewhere in this Agreement,
the terms set forh below have the meanings indicated for the purposes of this
Agreement.
"Affiliate" means any Person which controls, is controlled by or is under
common control with BNP or Supplier, as the case may be. The term "control"
means the ownership, directly or indirectly, of 50 percent or more of the
voting stock or equity interest of the subject Person.
"Designated Period" means the period commencing with the date of this
Agreement and ending on the third anniversary of the Manufacture Date of the
last lot of substance delivered by Supplier to BNP under this Agreement.
"DMF" means a Drug Master File for the Substance maintained by Supplier on
file with a Regulatory Authority.
"FDA" means the Food and Drug Administration or any successor agency of the
United States government.
"FDCA" means the United States Food, Drug and Cosmetic Act of 1938, as
amended from time to time, and the regulations and guidelines promulgated
pursuant thereto.
"GMP" means "good manufacturing practices," as that term is defined under the
FDCA.
"Manufacture Date" means, with respect to any lot of Substance, the date of
manufacture of such lot as coded in the label for that lot in accordance with
Supplier's normal labeling practices.
"Person" means any natural person, corporation, unincorporated organization,
partnership, association, joint stock company, joint venture, trust or
government, or any agency or political subdivision of any government, or any
other entity.
"Product" means a finished dosage form pharmaceutical product for human
consumption containing the Substance as an active ingredient.
"Protocols" means the analytical methods and procedures referred to in
Schedule 1 and Supplier Protocol [ ], as such analytical methods and
procedures have been provided to BNP in writing prior to the execution of
this Agreement.
"Regulatory Authorities" means the FDA and its foreign equivalents, as
applicable.
"Specifications" means the specifications for Substance attached as Schedule
1 attached hereto and incorporated herein, as the same may be amended from
time to time by mutual agreement of the parties.
"Substance" means paclitaxel bulk drug substance manufactured and released by
Supplier in accordance with GMP which satisfies the Specifications.
2. Supply
2.1 Agreement to Supply. On and subject to the terms and conditions of this
Agreement, Supplier shall manufacture and sell to BNP and BNP shall purchase
from Supplier, an aggregate of [ ] kilograms of Substance in such
quantities and at such times as are specified in Schedule 2 hereto.
2.2 Purchase Price; Escrow.
(a) The purchase price to be paid by BNP to Supplier for the Substance
conforming to this Agreement shall be US$[ ] per kilogram delivered.
The purchase price shall be paid as provided in Section 2.4(b), provided that
a portion of the purchase price shall be paid pursuant to escrow as provided
in Section 2.2(b).
(b) (i) Concurrently with the execution of this Agreement, the parties
shall execute and deliver an Escrow Agreement substantially in the form of
Exhibit A hereto, with Norwest Bank Colorado, National Association, or such
other financial institution as the parties may agree, as the Escrow Agent;
and BNP shall deposit the sum of US$[ ] (representing the purchase price
for the last US[ ] of Substance to be delivered by Supplier to BNP
pursuant to this Agreement) with the Escrow Agent to hold as the "Escrowed
Funds" in accordance with the Escrow Agreement. The Escrow Agreement
provides that the Escrow Agent shall make certain releases and deliveries on
the tenth banking day following receipt from Supplier (as "Seller") of a
"Delivery Notice" as prescribed in the Escrow Agreement unless, prior to that
day, the Escrow Agent has received a "Claim Notice" from BNP (as "Buyer") as
prescribed in the Escrow Agreement.
(ii) Supplier hereby agrees with BNP that Supplier will not deliver a
Delivery Notice to the Escrow Agent under the Escrow Agreement prior to the
earliest of the following events.
(A) Supplier has delivered to BNP all of the Substance required to be
delivered by Supplier under, and in accordance with, this Agreement, and at
least 30 days have elapsed after the last such delivery, and either (1) BNP
has not given Supplier notice of nonconformity as to any of such Substance
pursuant to Section 2.4(a) or (2) all of such Substance as to which BNP has
given such notice of nonconformity has been determined to be conforming
pursuant to Section 2.4(a); or
(B) Supplier has tendered for delivery to BNP all of the Substance required
to be tendered by Supplier under this Agreement (all of which Substance is in
conformance with the requirements therefor under this Agreement) to a date
upon which BNP repudiates its obligations under this Agreement or otherwise
by action or omission legally excuses Supplier from further performance under
this Agreement, and such repudiation or legal excuse, as the case may be,
remains in effect and does not arise out of any breach by Supplier.
Credits and refunds given by Supplier as contemplated in this Agreement shall
be included in determining the quantities of Substance that Supplier is
required to deliver or tender for delivery under this Agreement. Seller
agrees to give to BNP a copy of any Delivery Notice that it gives to the
Escrow Agent, no later than the time the Delivery Notice is given to the
Escrow Agent.
(iii) BNP hereby agrees with Supplier that it will not deliver a Claim
Notice to the Escrow Agent under the Escrow Agreement unless, to the time the
Claim Notice is delivered to the Escrow Agent, neither of the following has
occurred.
(A) Supplier has delivered to BNP all of the Substance required to be
delivered by Supplier under, and in accordance with, this Agreement, and at
least 30 days have elapsed after the last such delivery, and either (1) BNP
has not given Supplier notice of nonconformity as to any of such Substance
pursuant to Section 2.4(a) or (2) all of such Substance as to which BNP has
given such notice of nonconformity has been determined to be conforming
pursuant to Section 2.4(a);
(B) Supplier has tendered for delivery to BNP all of the Substance required
to be tendered by Supplier under this Agreement (all of which Substance is in
conformance with the requirements therefor under this Agreement) to a date
upon which BNP repudiates its obligations under this Agreement or otherwise
by action or omission legally excuses Supplier from further performance under
this Agreement, and such repudiation or legal excuse, as the case may be,
remains in effect and does not arise out of any breach by Supplier.
The parties agree that any dispute as to either party's rights to any portion
of the Escrowed Funds may be resolved by arbitration pursuant to Section
8.14, and each party shall participate in providing such instructions to the
Escrow Agent, with respect to the Escrowed Funds, as may be required by award
in such arbitration. Upon delivery of any portion of the Escrowed Funds to
Supplier, such delivered portion shall be credited toward BNP'S obligations
to pay the purchase price.
2.3 Shipment. Sales of the Substance shall be F.O.B. BNP'S Miami plant or
such other location within the United States of America as may be designated
by BNP. Supplier will bear all risk of loss, delay or damage in transit
until the Substance is actually received by BNP. Supplier shall pay all
costs related to the delivery of the Substance to BNP, including, without
limitation, all freight, insurance and handling charges. Title and risk of
loss to the Substance shall pass to BNP upon BNP's receipt of the Substance
at its designated delivery destination.
2.4 Product Inspection; Payment.
(a) All Substance received by BNP shall be subject to inspection and
testing by BNP within 30 days following BNP's receipt thereof. When the
results of any testing conducted within such period indicate that a lot of
delivered Substance does not meet the Specifications or any other provisions
of this Agreement, BNP will give Supplier notice thereof, identifying with
particularity the claims of nonconformance, within the applicable 30-day
period. Supplier shall have 30 days after receipt of BNP's notice within
which to give notice to BNP whether Supplier accepts or rejects BNP'S claims
of nonconformance. Any dispute arising under this Section 2.4(a) shall be
resolved by re-testing by a qualified testing laboratory acceptable to both
parties. The cost of the re-testing shall be borne by BNP if the lot is
shown to be conforming, and by Supplier if the lot is shown to be
nonconforming. Substance which is determined to be nonconforming pursuant to
the foregoing provisions may be rejected and returned to Supplier at
Supplier's expense including transportation and handling costs, provided that
BNP returns the nonconforming Substance to Supplier in accordance with
Supplier's instructions; provided, however, that, if Supplier does not
provide such instructions within 30 days after BNP's notice of rejection, or
the testing laboratory's determination of nonconformity, as the case may be,
then BNP may dispose of the nonconforming substance in such manner as it
determines, at Supplier's expense. Within 60 days after rejection of
Substance by BNP, or determination of nonconformity by the testing
laboratory, as the case may be, Supplier shall, at its option, either (i)
make replacement delivery of conforming Substance at no cost or charge to BNP
or (ii) issue full refund or credit to BNP for the amount paid or invoiced
for the nonconforming Substance. Supplier shall have no further obligation
to deliver replacement quantities of Substance as to which it has issued
refund or credit, and the total quantity purchasable by BNP under this
Agreement shall be reduced accordingly. Payment for Substance shall not be
deemed acceptance of such Substance.
(b) BNP shall pay Supplier the purchase price for conforming or otherwise
accepted Substance delivered to BNP no later than 30 days after the later of
(i) BNP's receipt of the Substance or (ii) determination of conformity by the
testing laboratory as contemplated in Section 2.4(a), as the case may be.
Notwithstanding the foregoing, the purchase price for the last US$[ ] of
Substance to be delivered by Supplier to BNP shall be deposited in escrow by
BNP as contemplated in Section 2.2(b) and, upon delivery of any portion of
the Escrowed Funds to or for the benefit of Supplier as contemplated in
Section 2.2(b), such delivered portion shall be credited toward BNP's
obligations to pay the purchase price.
3. Regulatory Matters and Manufacturing Standards
3.1 Maintenance of Drug Master File.
(a) During the Designated Period, Supplier shall, at Supplier's expense,
(i) maintain DMFs on file with the FDA and with such other Regulatory
Authorities as Supplier may determine or as BNP may request from time to
time, and comply with the requirements of the Regulatory Authorities with
respect thereto; (ii) amend the DMFs to permit BNP to incorporate by
reference all data and information in the DMFs which BNP requires in support
of its submissions to any of the Regulatory Authorities for Product which
utilize the Substance; (iii) timely and fully respond to the [ ]
issued by the FDA to Supplier in [ ] and to the items relating
to Substance contained in the major amendment letter issued by the FDA to
[ ] in [ ], and resolve any deficiencies contained in
such letters related to Supplier's facilities and/or the Substance to the
satisfaction of the FDA; (iv) use its best efforts to resolve other deficiencies
identified by any Regulatory Authority which materially and adversely affect
BNP's use of the Substance in Product, including without limitation by using its
best efforts to provide such documentation, data and information and making
such corrections as the Regulatory Authorities may require (in considering the
efforts required of Supplier, it is recognized that Supplier intends to exit
from the business of manufacturing paclitaxel bulk drug substance and that
such exit may limit the efforts it is able to make, but Supplier shall in any
event remain able, during the Designated Period, to provide to the Regulatory
Authorities the documentation, data, and information, as to Substance
delivered or to be delivered under this Agreement, that it would compile in
the ordinary course of business and in accordance with the requirements of
the Regulatory Authorities if it were not exiting the business); and (v)
cooperate with BNP in connection with BNP's submissions to the Regulatory
Authorities for approval of Product.
(b) Supplier shall not make any change to any DMF without the prior written
approval of BNP, which approval shall not be unreasonably withheld. Supplier
shall provide BNP with one copy of the non-proprietary portion of each DMF
and any non-proprietary updates and amendments thereto promptly upon
completion thereof. Promptly upon BNP's request, Supplier agrees to provide
BNP with any required authorization to allow all applicable Regulatory
Authorities to access, review and refer to the DMFs in connection with any
regulatory submissions or product applications by BNP and its designees. At
the request of BNP or any Regulatory Authority, Supplier shall execute and
deliver to BNP, or to the Regulatory Authority with a copy to BNP, as
applicable, any further documents that BNP or the Regulatory Authority may
request to evidence the rights of BNP hereunder.
(c) After Supplier has delivered [ ] kilograms of conforming Substance
to BNP and has fully performed and completed its obligations under
3.1(a)(iii) above, Supplier, at its option, may assign and transfer any or
all of the DMFs to BNP (or its designee), provided that such assignment and
transfer can be made without any material adverse effect on BNP, the Product,
approval of the Product, the DMFs or BNP'S marketing, sale or use of the
Substance or Product, and BNP will cooperate to accomplish such assignment
and transfer.
(d) During the Designated Period, Supplier shall monitor the stability of
the Substance and comply with the DMF as on file with the FDA in accordance
with its regulatory obligations under the FDCA and in accordance with
Schedule 1. Without limiting the generality of the foregoing, during the
Designated Period and thereafter for the period ending with the fifth
anniversary of the Manufacture Date of the last lot of Substance delivered by
Supplier to BNP under this Agreement (the period beginning with the end of
the Designated Period and ending on such fifth anniversary being the
"Extended Period"), Supplier shall sample the paclitaxel bulk drug substance
that it manufactures in compliance with Supplier Protocol [ ],
will monitor stability of such samples in accordance with Supplier Protocol
[ ], and will notify BNP promptly if, during the Designated Period
or the Extended Period, any of such samples fails to meet the stability
parameters of Supplier Protocol [ ]; provided, however, that
Supplier may, at any time following the expiration of the Designated Period
but before the expiration of the Extended Period, transfer all of such
samples and stability data to BNP, so that BNP may continue to so monitor the
stability of such samples. Supplier represents to BNP that Supplier Protocol
[ ] is in conformity with the requirements of the International
Conference on Harmonization guidelines with respect to stability testing for
active drug substances. Nothing in this Section 3.1(d) shall be deemed to
constitute a representation or warranty by Supplier as to the stability or
any other characteristic of the Substance, the only such warranties being
made as provided in Section 4.1.
3.2 Lot Certifications. Supplier shall perform full release testing for
each lot of Substance delivered to BNP and shall obtain and retain a
representative sample from each such lot. Supplier shall assay and analyze
each such lot in strict accordance with the Protocols. Supplier shall
provide to BNP, with each delivery of Substance, a copy of the certificate of
analysis for each lot included in the delivery, together with such other
information as BNP shall reasonably request in connection therewith.
3.3 Notification of Adverse Events. During the Designated Period, Supplier
shall, immediately upon becoming aware thereof, inform BNP of (a) any pending
or threatened litigation, governmental investigation, proceeding or action
involving the Substance or Supplier's manufacturing facilities for the
Substance, (b) any defective, adulterated or misbranded Substance, (c) any
information suggesting that the Substance is defective or fails to meet the
Specifications.
4. Warranties and Indemnity
4.1 Representations, Warranties and Covenants. Supplier makes to BNP the
representations, warranties and covenants set forth in Schedule 3 and also
represents, warrants and covenants to BNP that: (a) Supplier shall obtain and
maintain all necessary permits, registrations and licenses required to
manufacture and supply the Substance under this Agreement, including without
limitation registration of the establishment where the Substance is
manufactured and stored; (b) Supplier will comply with all laws, rules and
regulations, including all GMP, applicable to the manufacture, labeling,
packaging, storage and shipment of the Substance in effect from time to time;
(c) the Substance supplied pursuant to this Agreement shall fully conform
with the quality and other requirements of the Specifications; (d) the
Substance shall not be adulterated or misbranded within the meaning of the
FD&C Act, and shall not be a product that would violate any section of the
FD&C Act if introduced into interstate commerce; (e) during the Designated
Period, the Substance shall be stable as contemplated in Supplier Protocol
[ ], with delivery to by Supplier to BNP at ambient temperature,
provided that it is continuously stored, following such delivery to BNP, in
accordance with the recommended storage conditions specified in Supplier
Label [ ](as such label has been provided to BNP in writing prior to
the execution of this Agreement) at temperatures within the range of
[ ]; (f) the Substance and the sale or use of the Substance by BNP or
its Affiliates will not infringe any patent, trademark, copyright or other
rights of third parties; and (g) Supplier has full right and authority to enter
into this Agreement without the consent or approval of any third party.
4.2 Indemnity by Supplier. Supplier shall indemnify and hold BNP and its
Affiliates and their respective officers, directors and employees harmless
from and against any and all liability, damage, loss, cost or expense
(including attorney's fees and expenses) arising out of or resulting from any
third party claims made or suits brought against any of such parties which
arise or result from the breach by Supplier of any of Supplier's
representations, warranties, covenants and agreements under this Agreement,
except to the extent such liability, damage, loss, cost or expense arises out
of or results from the breach by BNP of any of BNP's representations,
warranties, covenants and agreements under this Agreement, or from the
negligence or willful misconduct of BNP.
4.3 Indemnity by BNP. BNP shall indemnify and hold Supplier and its
Affiliates and their respective officers, directors and employees harmless
from and against any and all liability, damage, loss, cost or expense
(including attorney's fees and expenses) arising out of or resulting from any
third party claims made or suits brought against any of such parties which
arise or result (a) from BNP's use or sale of Product or (b) from the breach
by BNP of any of BNP's representations, warranties, covenants and agreements
under this Agreement, except to the extent such liability, damage, loss, cost
or expense arises out of or results from the breach by Supplier of any of
Supplier's representations, warranties, covenants and agreements under this
Agreement, or from the negligence or willful misconduct of Supplier.
5. Confidentiality
5.1 Confidential Information. During the period from the date hereof
through the tenth anniversary of the date hereof, each party shall keep
confidential and not disclose to others or use for any purpose, other than as
authorized by this Agreement, all confidential information which was provided
to it by the other party or its Affiliates or their respective employees or
representatives ("Confidential Information"). The restrictions of this
Section 5 shall not apply to any Confidential Information which (a) is
already known to the recipient at the time of disclosure; (b) is or becomes
public knowledge through no fault of the recipient; (c) is received from a
third party having the lawful right to disclose the information; (d) subject
to Section 5.2, is required by law to be disclosed; (e) is required to be
disclosed in order to exercise rights granted or retained pursuant to this
Agreement; or (f) is required to be disclosed by BNP in connection with any
applications filed with Regulatory Authorities or in connection with its
marketing and sale of the Product.
5.2 Required Disclosure. If either party is required under applicable law
to disclose Confidential Information by any court or to any governmental
authority, the party required to disclose the Confidential Information shall,
prior to such disclosure, notify the other party of such requirement and all
particulars related to such requirement. The notified party shall have the
right, at its expense, to object to such disclosure and to seek confidential
treatment of any Confidential Information to be so disclosed on such terms as
it shall determine, and the other party shall fully cooperate with the
notified party in this regard.
5.3 Return of Confidential Information. This Agreement does not constitute
the conveyance of ownership with respect to or a license to any Confidential
Information. Upon the expiration or termination of this Agreement for any
reason, each party agrees to return to the other party all documentation or
other tangible evidence or embodiment of Confidential Information belonging
to the other party.
6. Inspections
6.1 Regulatory Inspections. Supplier agrees to promptly notify BNP of any
inspections by any Regulatory Authority which pertain to the Substance or the
premises where the Substance is manufactured, and shall promptly provide to
BNP copies of all correspondence, reports, notices, findings and other
material pertinent to such inspections, as they are received or produced by
Supplier.
6.2 Access. BNP shall have the right, upon notice to Supplier and during
normal business hours, not more than once during any calendar year, to
inspect and audit Supplier's facilities at which the Substance is
manufactured, packaged or stored, in order to ensure that the Substance is
being manufactured, packaged and stored in compliance with the
Specifications, current GMP and all applicable laws and regulations. During
such inspections, Supplier shall permit BNP to contact and question the
appropriate knowledgeable personnel of Supplier responsible for
manufacturing, packaging and storing the Substance. Supplier shall make
available to BNP and its duly authorized representatives and agents all
books, records and documents which in any way pertain to the manufacture of
the Substance or quality control testing and compliance procedures.
7. Product Recall
7.1 Product Recall. If, during the Designated Period, (a) any Regulatory
Authority shall rightfully seize any of the Substance or Product or shall
request or require the recall of any of the Product or (b) BNP deems it
necessary to initiate a voluntary recall of any Product, and if the cause or
reason for any such seizure or recall relates to the Substance and (in the
case of a seizure or recall by reason of the action of a Regulatory
Authority) the Regulatory Authority has issued a warning letter to Supplier,
then Supplier shall be responsible for and shall indemnify and hold BNP and
its Affiliates and their respective officers, directors and employees
harmless from and against any and all claims, losses, damages and
liabilities, including attorneys fees and expenses, relating to such recall
and seizure, including, without limitation, the cost of notifying customers,
the costs associated with the shipment of recalled Product from BNP's
customers, the cost of the Substance and all credits extended to BNP's
customers as a result thereof, and all other costs of effecting such seizure
or recall.
8. Miscellaneous.
8.1 Notice. All notices, requests, consents and other communications
required or permitted under this Agreement shall be in writing and shall be
(as elected by the person giving such notice) hand delivered by messenger or
courier service, telecommunicated, or mailed by registered or certified mail
(postage prepaid), return receipt requested, addressed to:
If to BNP: Baker Norton Pharmaceuticals, Inc.
4400 Biscayne Boulevard
Miami, Florida 33137
Attention: Vice President
Facsimile: (305) 575-6027
Confirming telephone: (305) 575-6004
with a copy to: IVAX Corporation
4400 Biscayne Boulevard
Miami, Florida 33137
Attention: General Counsel
Facsimile: (305) 575-6049
Confirming telephone: (305) 575-6031
If to Supplier: Hauser, Inc.
5555 Airport Boulevard
Boulder, Colorado 80301
Attention: President
Facsimile: (303) 441-5802
Confirming telephone: 303-443-4662
Each such notice shall be deemed delivered (1) on the date delivered if by
personal delivery, (2) on the date telecommunicated if by facsimile, and (3)
on the date upon which the return receipt is signed or delivery is refused or
the notice is designated by the postal authorities as not deliverable, as the
case may be, if mailed. By giving to the other parties at least 15 days
written notice thereof, the parties and their respective successors and
permitted assigns shall have the right from time to time to change their
respective addresses.
8.2 Further Assurances. Each party agrees to execute and deliver any and
all such other and additional instruments and documents and do any and all
such other acts and things as may be necessary or expedient to effectuate
more fully this Agreement and to carry out the business contemplated by this
Agreement.
8.3 Survival. The indemnification, confidentiality and other obligations
of the parties shall not be affected or impaired by and shall survive
completion of delivery of and payment for [ ] kilograms of Substance.
8.4 Force Majeure. The inability of any party to commence or complete its
obligations hereunder by the dates herein required resulting from delays
caused by strikes, insurrection, acts of God, war, emergencies, shortages or
unavailability of materials, or other causes beyond the party's reasonable
control which shall have been timely communicated to the other party, shall
extend the period for the performance of the obligations for the period equal
to the period(s) of any such delays(s); provided that such party shall
continue to perform to the extent feasible in view of such force majeure; and
provided further, that if such force majeure shall continue for a period of
six months, the other party shall have the right to terminate this Agreement
upon written notice to the party unable to perform.
8.5 Assignment; Binding Effect. This Agreement may not be assigned by
Supplier without the written consent of BNP. Subject to the foregoing, this
Agreement shall be binding upon and inure to the benefit of the parties
hereto and their respective successors and permitted assigns.
8.6 Waiver and Amendment. Any representation, warranty, covenant, term or
condition of this Agreement which may legally be waived, may be waived, or
the time of performance thereof extended, at any time by the party hereto
entitled to the benefit thereof, and any term, condition or covenant
(including, without limitation, the period during which any condition is to
be satisfied or any obligation performed) may be amended by the parties
hereto at any time. Any such waiver, extension or amendment shall be
evidenced by an instrument in writing executed by an officer authorized to
execute waivers, extensions or amendments. No waiver by any party, whether
express or implied, of its rights under any provision of this Agreement shall
constitute a waiver of such party's rights under such provisions at any other
time or a waiver of such party's rights under any other provision of this
Agreement. No failure by any party to take any action against any breach of
this Agreement or default by another party shall constitute a waiver of the
former party's right to enforce any provision of this Agreement or to take
action against such breach or default or any subsequent breach or default by
such other party.
8.7 Entire Agreement. This Agreement and the Exhibit attached hereto
contain every obligation and understanding between the parties relating to
the subject hereof and merges all prior discussions, negotiations and
agreements, if any, between them, and none of the parties shall be bound by
any conditions, definitions, understandings, warranties or representations
other than as expressly provided or referred to herein.
8.8 Severability. In the event that any one or more of the provisions
contained in this Agreement shall be declared invalid, void or unenforceable,
in any country, the remainder of the provisions of this Agreement shall
remain in full force and effect, and such invalid, void or unenforceable
provision shall be interpreted in such country in a manner which
accomplishes, to the extent possible, the original purpose of such provision.
8.9 Section Headings. The section headings in this Agreement are for
convenience of reference only and shall not be deemed to affect the
interpretation of any provision of this Agreement.
8.10 No Third Party Rights. The provisions of this Agreement are for the
exclusive benefit of the parties to this Agreement, and no other Person
(including without limitation any creditor of any party to this Agreement)
shall have any right or claim against any party to this Agreement by reason
of those provisions or be entitled to enforce any of those provisions against
any party to this Agreement.
8.11 Relationship of Parties. This Agreement shall not constitute or be
construed as creating a partnership or joint venture between BNP and
Supplier, and neither party shall be liable for any debts or obligations of
the other party. BNP shall in no way be considered as being an agent or
representative of Supplier in any dealings which BNP may have with any third
party, and BNP may neither act for, nor bind, Supplier in any such dealings.
8.12 Construction. The parties acknowledge that each has been advised by
counsel during the course of negotiation of this Agreement and, therefore,
that this Agreement shall be interpreted without regard to any presumption or
rule requiring construction against the party causing this Agreement to be
drafted.
8.13 Governing Law. This Agreement has been entered into and shall be
construed and enforced in accordance with the laws of the State of New York
without reference to the choice of law principles thereof.
8.14 Arbitration. All disputes arising out of or relating to this
Agreement or to the breach or validity thereof shall be finally settled by an
arbitration proceeding to be held at a neutral location that is mutually
agreeable to the parties (or is determined by the American Arbitration
Association if the parties are not able to agree) under the Commercial Rules
of Arbitration of the American Arbitration Association by three neutral
arbitrators appointed in accordance with those rules. The decision of the
arbitrators shall be binding and conclusive upon each party hereto and may be
enforced in any court of competent jurisdiction. At least one of the
arbitrators shall have substantial experience in pharmaceutical supply
agreements. The arbitrators shall be specifically empowered to render a
decree requiring specific performance.
8.15 Equitable Remedies. Each of the parties acknowledges and agrees that,
in the event of a breach or threatened breach of this Agreement by any party
or the failure of a party to perform in accordance with the specific terms
hereof, the other party hereto will be irreparably damaged and that monetary
damages would not provide an adequate remedy. Accordingly, it is agreed
that, in addition to any and all other rights which may be available, at law
or in equity, the non-breaching party shall be entitled to injunctive relief
and/or specifically to enforce the terms and provisions hereof in any court
of competent jurisdiction.
8.16 Remedies Cumulative. The rights and remedies given in this Agreement
to a nondefaulting party shall be deemed cumulative, and the exercise of one
of such remedies shall not operate to bar the exercise of any other rights
and remedies reserved to a nondefaulting party under the provisions of this
Agreement or given to a nondefaulting party at law or in equity.
8.17 Prevailing Party. If either party commences an action against the
other to interpret or enforce any of the terms of this Agreement or as a
result of a breach by the other party of any of its terms, the prevailing
party shall be entitled to recover from the nonprevailing party attorneys'
fees, costs and expenses incurred by the prevailing party in connection with
such action.
8.18 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.
8.19 English Version. In the event that this Agreement is translated into
a language other than English, the English version of this Agreement shall
control all questions of interpretation with respect thereto.
8.20 Press Releases. Neither party shall issue any press release or other
publicity materials, or make any presentation with respect to the existence
of this Agreement or the terms and conditions thereof without the prior
written consent of the other party. However, this restriction shall not
apply to disclosures required by law or regulation.
[Signatures follow.]
IN WITNESS WHEREOF, the parties have executed this Agreement by their
authorized representatives effective as of the date first above written.
HAUSER, INC.
By: /s/David I. Rosenthal
Name: David I. Rosenthal
Title: Chief Financial Officer and Treasurer
BAKER NORTON
PHARMACEUTICALS, INC.
By: /s/Jane Hsiao
Name: Jane Hsiao
Title: Vice President
<PAGE>
SCHEDULE 1
Specifications
<TABLE>
<S> <C> <C>
Characteristic Test Method Description
Appearance Visual [ ]
Identity IR [ ]
HPLC [ ] [ ]
Specific rotation [ ] [ ]
Assay [ ] [ ]
Individual impurities [ ] [ ]
Specific Impurity Index Maximum
Impurity Allowable Area (%)
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
Organic volatile [ ] [ ]
Impurities [ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
Moisture (Karl Fischer) [ ] [ ]
Residue on Ignition [ ] [ ]
Heavy Metals [ ] [ ]
Bacterial Endotoxins [ ] [ ]
Total Microbial Count [ ] [ ]
</TABLE>
<PAGE>
SCHEDULE 2
Shipments
Shipments will begin with approximately [ ] kilograms and will continue to
be shipped as the Substance is produced, not to exceed [ ] kilograms per
month.
<PAGE>
SCHEDULE 3
Additional Representations, Warranties and Covenants
Pursuant to Section 4.1 of the Agreement to which this schedule is attached,
Supplier makes the following representations, warranties and covenants to
BNP:
1. Supplier has the right (to the exclusion of any third party) to grant BNP
the right to reference the DMFs as contemplated in the Agreement, subject to
applicable law, and Supplier owns all right, title and interest (to the
exclusion of any third party) in and to the DMFs to which BNP is or may be
granted such right of reference.
2. The harvesting operations for all raw materials used to manufacture
Substance shall comply with all pertinent permits, land use and environmental
regulations of applicable Regulatory Authorities. Supplier shall be
responsible for disposing in an environmentally safe manner any and all
residue resulting from manufacture of Substance. Supplier agrees that it
shall adopt and follow safe handling, storage, transportation, use, treatment
and disposal practices in connection with Supplier's collection of raw
materials and its manufacture of Substance, including but not limited to, all
such practices required by federal, state and local government law. Supplier
shall instruct its employees, independent contractors and agents of any
precautions or safe use practices required in the handling, manufacture,
storage or disposal of all materials required for Supplier's collection of
raw materials and its production of Substance. Supplier possesses skill and
expertise in the safe handling, storage, manufacture and disposal of said
products. All of the Substance sold under the Agreement shall be produced
from Taxus biomass that has been gathered or cultivated in compliance with
any applicable federal, state or provincial laws and regulations. Supplier
shall provide BNP, in writing, with all pertinent information available
regarding handling precautions and hazards associated with Substance,
including without limitation a current Material Safety Data Sheet.
3. Supplier has good and marketable title to, and the right to sell to BNP
in accordance with the Agreement, the Substance and, at the time of delivery
of the Substance to BNP, the Substance shall be free and clear of any liens
or encumbrances other than those created or suffered by or under BNP.
4. Supplier is not debarred under the FD&C Act and it does not and will not
use in any capacity the services of any Person debarred under the FD&C Act.
Neither Supplier, nor, to the best of its knowledge, any of its employees,
agents or contractors has engaged in any activity that could lead to it
becoming debarred under the FD&C Act.
5. Supplier shall conduct its manufacturing operations hereunder in a safe
and prudent manner, in compliance with all applicable laws and regulations
(including, but not limited to, those dealing with occupational safety and
health, those dealing with public safety and health, those dealing with
protecting the environment, and those dealing with disposal of wastes), and
in compliance with all applicable provisions of this Agreement.
[End of Schedule 3.]
CONFIDENTIAL TREATMENT OF REDACTED PORTIONS HAS BEEN GRANTED BY THE SEC
Exhibit 10.2
CONFIDENTIAL TREATMENT OF REDACTED PORTIONS HAS BEEN GRANTED BY THE SEC
Execution Document
February 3, 1999
ESCROW AGREEMENT
This Escrow Agreement (this "Agreement") is among Hauser, Inc., a Colorado
corporation ("Seller"); Baker Norton Pharmaceuticals, Inc., a Florida
corporation ("Buyer"); and Norwest Bank Colorado, National Association (the
"Escrow Agent"). Seller and Buyer are sometimes referred to collectively as
the "Escrowing Parties."
RECITALS
WHEREAS, the Escrowing Parties agree to place in escrow certain funds and the
Escrow Agent agrees to hold and distribute such funds in accordance with the
terms of this Escrow Agreement, the Escrow Agent and the Escrowing Parties
make this agreement as follows:
ARTICLE 1: DIRECTIONS
1.01 ESCROWED FUNDS:
With its execution and delivery hereof, Buyer is depositing with the Escrow
Agent the sum of [ (US$ )] (the "Escrowed Funds")
in the form of a bank cashiers' check, certified wire transfer, or other
immediately available funds payable to the order of the Escrow Agent.
1.02 INSTRUCTIONS:
(a) The Escrow Agent shall invest the Escrowed Funds in such manner as may
be directed by written instructions signed by both Seller and Buyer,
provided, however, that, in the absence of such instructions the Escrow Agent
shall invest the Escrowed Funds in an interest-bearing account of a federally
insured financial institution (which may be the Escrow Agent or any of its
affiliated financial institutions).
(b) If and when the Escrow Agent receives, at the address stated for the
Escrow Agent above its signature at the end of this Escrow Agreement, written
notice (the "Delivery Notice") from Seller stating (A) that Seller is
entitled to the Escrowed Funds under the terms of the Supply Agreement and
(B) that Seller has given notice to Buyer that Seller is making the Delivery
Notice, then the Escrow Agent shall (i) furnish Buyer with a copy of the
Delivery Notice within two banking days after Escrow Agent's receipt thereof
and (ii) on the tenth banking day after its receipt of the Delivery Notice
(such tenth day being the "Delivery Date").
(1) Deduct, from the aggregate of the Escrowed Funds and interest accrued
thereon, the Escrow Agent's Fees, as determined pursuant to Article 2;
(2) Release and deliver to Seller the lesser of (i) the Escrowed Funds,
excluding interest accrued thereon, or (ii) the amount remaining after
deducting the Escrow Agent's fees from the aggregate of the Escrowed Funds
and interest accrued thereon; and
(3) Release and deliver to Buyer the amount, if any, remaining of the
aggregate of the Escrowed Funds and interest accrued thereon after making the
deductions and deliveries provided for in Section 1.02(b)(1) and Section
1.02(b)(2).
(c) Notwithstanding Section 1.02(b), the Escrow Agent shall not make the
deductions, releases and deliveries provided for in Section 1.02(b) if, prior
to the Delivery Date, the Escrow Agent shall have received, at the address
stated for the Escrow Agent above its signature at the end of this Escrow
Agreement, written notice (the "Claim Notice") from Buyer stating (1) that
Seller is not entitled to the Escrowed Funds under the terms of the Supply
Agreement and (2) that Buyer is entitled to file the Claim Notice under the
terms and conditions of the Supply Agreement. The Escrow Agent shall furnish
Seller with a copy of the Claim Notice within two banking days of the Escrow
Agent's receipt thereof.
(d) If the Escrow Agent receives a Claim Notice as contemplated in Section
1.02(c), the Escrow Agent shall release and deliver the Escrowed Funds as
directed by written instructions signed by both Seller and Buyer, which
instructions may direct the Escrow Agent (A) to release all of the Escrowed
Funds to Seller, (B) to release all of the Escrowed Funds to Buyer, (C) to
release a stated portion or percentage of the Escrowed Funds to one of them
and the balance to the other, or (D) to release the Escrowed Funds as
otherwise directed in the written instructions; provided, however, that, if
the Escrow Agent does not receive such written instructions within six months
following receipt of a Claim Notice, the Escrow Agent shall continue to hold
the Escrowed Funds pursuant to this Agreement pending receipt of such written
instructions until the Escrow Agent determines in its discretion to proceed
in accordance with Section 3.08.
1.03 ASSIGNMENT OF INTEREST:
The assignment, transfer, conveyance, or hypothecation of any right title, or
interest in and to the subject matter of this Agreement (referred to under
this Section 103 as "Assignment') shall be binding upon the Escrow Agent upon
delivery of notice to the Escrow Agent of the Assignment and payment to the
Escrow Agent of all of its fees, in connection with the Assignment, provided
the Escrow Agent has given its written assent to the Assignment, which assent
shall not be unreasonably withheld.
ARTICLE 2: COMPENSATION OF THE ESCROW AGENT
The Escrowing Parties agree, jointly and severally, to pay the Escrow Agent
the following ("Escrow Agent's Fees"):
(a) [ ] inception fee and [ ] annual administration fee for all
services rendered by it under this Agreement; and
(b) Reasonable compensation for services rendered in connection with this
Agreement but not expressly provided for herein and reimbursement for those
reasonable expenses incurred by the Escrow Agent in rendering such services,
including, but not limited to court costs and attorney's fees incurred as a
result of any dispute arising out of this Agreement.
Provision is made in Section 1.02(b)(1) for the deduction of the Escrow
Agent's Fees in connection with release and delivery of the Escrowed Funds.
The Escrow Agent shall have a first and prior lien upon the Escrowed Funds to
secure the payment of the Escrow Agent's Fees. If any such payment is not
timely received by the Escrow Agent the Escrowing Parties authorize the
Escrow Agent to deduct such payment from the Escrowed Funds.
ARTICLE 3: PROVISIONS CONCERNING ESCROW AGENT
3.01 AUTHORITY OF ESCROWING PARTIES:
The Escrow Agent shall be under no duty or obligation to ascertain the
identity, authority, and/or rights of the Escrowing Parties or their agents.
3.02 OTHER AGREEMENTS:
The Escrow Agent shall not be a party to, or bound by, any agreement between
the Escrowing Parties other than this Agreement, whether or not a copy and/or
original of such agreement is held as escrowed property under this Agreement,
and, the Escrow Agent shall have no duty to know or inquire as to the
performance or nonperformance of any provision of any such agreement between
the Escrowing Parties.
3.03 DEPOSITED INSTRUMENTS AND/OR FUNDS:
The Escrow Agent assumes no responsibility for the validity or sufficiency of
any instrument held as Escrowed Funds, except as expressly and specifically
set forth in this Agreement.
3.04 LATE PAYMENTS OR PERFORMANCE:
The Escrow Agent may not accept any payment or performance required under
this Agreement after the date such payment or performance is due, except as
the Parties may otherwise jointly instruct the Escrow Agent in writing
subsequent to the date such payment or performance is due but prior to the
actual date of payment or performance.
3.05 ESCHEAT:
The Escrowing Parties are aware that under Colorado law, escrowed property
which is presumed abandoned may escheat to the State. The Escrow Agent shall
have no liability to the Escrowing Parties, their respective heirs, legal
representatives, successors, and assigns, should any or all of the Escrowed
Funds become escheat able or escheat by operation of law.
3.06 NON-LIABILITY:
The Escrow Agent shall not be liable for any act or omission while acting in
good faith and in the exercise of its own best judgment. Any act or omission
by the Escrow Agent pursuant to the advice of its attorneys shall be
conclusive evidence of such good faith. The Escrow Agent shall have the
right to consult with counsel at the expense of the Escrowing Parties
whenever any question arises concerning this Agreement and shall incur no
liability for any delay reasonably required to obtain such advice of counsel.
The Escrow Agent shall have no further responsibility or liability whatsoever
to any or all of the Escrowing Parties following a complete distribution of
the Escrowed Funds pursuant to this Agreement. The Escrow Agent shall not
incur any liability with respect to any act or omission in reliance upon any
document including any written notice or instruction provided for in this
Agreement. In performing its obligations hereunder, the Escrow Agent shall
be entitled to presume, without inquiry, the due execution, validity and
effectiveness of all documents it receives, and also the truth and accuracy
of any information contained therein. The Escrow Agent shall not be
responsible or liable for any diminution of principal of the Escrowed Funds
or any interest penalty, whatsoever, for any reason.
3.07 INDEMNIFICATION:
The Escrowing Parties agree, jointly and severally, to indemnify and hold
harmless the Escrow Agent from any liability, cost, or expense whatsoever,
including, but not limited to, attorney's fees incurred by reason of
accepting this Agreement and/or Escrowed Funds.
3.08 DISAGREEMENTS.
If any disagreement or dispute arises between the Escrowing Parties
concerning the meaning or validity of any provision hereunder or concerning
any other matter relating to this Agreement, the Escrow Agent.
(a) Shall be under no obligation to act, except under process or order of
court or until it has been adequately indemnified to its full satisfaction,
and shall sustain no liability for its failure to act pending such process,
court order or indemnification; and
(b) May, in its sole and absolute discretion, interplead the Escrowed Funds
or that portion of Escrowed Funds it then holds with the District Court of
the City and County of Denver, State of Colorado, and name the Escrowing
Parties in such interpleader action. Upon filing the interpleader action,
the Escrow Agent shall be relieved of all liability as to the Escrowed Funds
and shall be entitled to recover from the Escrowing Parties its reasonable
attorneys' fees and other costs incurred in commencing and maintaining such
action, The Escrowing Parties by signing this Agreement submit themselves to
the jurisdiction of such court and do appoint the Clerk of such Court as
their agent for the service of all process in connection with such
proceedings In no event shall the institution of such interpleader action
impair the rights of the Escrow Agent described in Section 3.06 of this
Article.
ARTICLE 4: GENERAL TERMS AND CONDITIONS
4.01 EXTENSION OF BENEFITS:
This agreement shall be binding upon, inure to the benefit of, and be
enforceable by, the respective heirs, legal representatives, successors, and
assigns of all of the Escrowing Parties and the Escrow Agent.
4.02 GOVERNING LAW:
This Agreement shall be construed and enforced in accordance with the laws of
the State of Colorado.
4.03 NOTICES:
All notices, requests, demands, and other communications required under this
Agreement shall be in writing and shall be deemed to have been duly given if
delivered personally or by certified mail, return receipt requested and
postage prepaid, addressed as set forth below under the signature lines of
the respective addressees of such communications, provided that an addressee
may change the address for communications to it by giving notice of such
change to a communicating party, which change shall become effective as to
that communicating party on the later of the effective date stated in the
notice of change or the tenth day after the notice of change is given. If
any notice is mailed, it shall be deemed given on the date on which the
return receipt is signed or delivery is refused or the notice is designated
by the postal authorities as not deliverable, as the case may be. If any
notice is personally delivered, it shall be deemed given upon the date of
such delivery. If notice is given to a party, it shall be mailed or
delivered to the addresses set forth below the signature blocks. It shall be
the responsibility of the Escrowing Parties to notify the Escrow Agent in
writing of any name or address changes.
4.04 ENTIRE AGREEMENT:
This Agreement sets forth the entire agreement and understanding of the
Escrowing Parties hereto.
4.05 AMENDMENT:
This Agreement may be amended, modified, superseded, rescinded, or canceled
only by a written instrument executed by the Escrowing Parties and the Escrow
Agent.
4.06 WAIVERS:
The failure on any party to this Agreement at any time or times to require
performance of any provision under this Agreement shall in no manner affect
the right at a later time to enforce the same performance. A waiver by any
party to this Agreement of any such condition or breach of any term,
covenant, representation, or warranty contained in this Agreement, in any one
or more instances, shall neither be construed as a further or continuing
waiver of any such condition or breach nor a waiver of any other condition or
breach of any other term, covenant, representation or warranty contained in
this Agreement.
4.07 HEADINGS:
Section headings of this Agreement have been inserted for convenience of
reference only and shall in no way restrict or otherwise modify any of the
terms or provisions of this Agreement.
4.08 COUNTERPARTS:
This Agreement may be executed in one or more counterparts, each of which
when executed shall be deemed to be an original, and such counterparts shall
together constitute one and the same instrument.
4.09 RESIGNATION OR REMOVAL OF ESCROW AGENT:
The Escrow Agent may resign at any time by furnishing written notice of its
resignation to the Escrowing Parties. The Escrowing Parties may remove the
Escrow Agent at any time by furnishing to the Escrow Agent a written notice
of its removal. Such resignation or removal, as the case may be, shall be
effective upon delivery of such notice.
[Signatures follow]
IN WITNESS WHEREOF, the Escrowing Parties to this Agreement have each caused
this Escrow Agreement to be duly executed on this third day of February 1999.
Corporate Name: BAKER NORTON PHARMACEUTICALS, INC.
By: /s/Jane Hsiao
Title: Vice President
Address: 4400 Biscayne Boulevard
Miami, Florida 33137
Telephone: (305) 575-6004
Tax I.D. N :
Corporate Name: HAUSER, INC.
By: /s/David I. Rosenthal
Title: Chief Financial Officer and Treasurer
Address: 5555 Airport Boulevard
Boulder, Colorado 80301
Telephone: (303) 443-4662
Tax I.D. N :
A copy of all notices to Baker Norton Pharmaceuticals, Inc. shall be sent to:
IVAX Corporation
4400 Biscayne Boulevard
Miami, Florida 33137
Attention: General Counsel
Telephone: (305)575-6037
The Escrow Agent by affixing its signature below, hereby acknowledges receipt
of the Escrowed Funds and agrees to hold, administer, and dispose of the
Escrowed Funds in accordance with the terms, conditions, and instructions of
this Agreement and any amendments thereto, including those set forth in
Schedule A.
Norwest Bank Colorado, National Association
Escrow Agent
Date: By:
Account No. Title:
c/o Norwest Investment Management and Trust
Corporate Trust and Escrow Services
1740 Broadway
Denver, Colorado 80274-8693
Phone: (303) 863-6247 Fax: (303) 863-5645
<PAGE>
SCHEDULE A TO ESCROW AGREEMENT
Joint Written Investment Instructions
Pursuant to Section 1-02(a) of the Escrow Agreement among Hauser, Inc.. a
Colorado corporation ("Seller"); Baker Norton Pharmaceuticals, Inc., a
Florida corporation] ("Buyer"); and Norwest Bank Colorado, National
Association (the "Escrow Agent"), the Seller and Buyer ("Escrowing Parties")
direct the Escrow Agent to invest the Escrowed Funds as follows:
The sum of [ (US$ )] be invested in the Cash
Investment Fund of the Norwest Advantage Fund Group.
The Escrowed Funds will remain invested in the Norwest Cash Investment Fund
until such time as Escrowing Parties supply new instructions for the
investment of the Escrowed Funds or until the Escrowed Funds are released and
delivered as provided in the Escrow Agreement
IN WITNESS WHEREOF, the parties have executed these instructions by their
authorized representatives effective as of the date first above written.
HAUSER, INC.
By: /s/David I. Rosenthal
Name: David I. Rosenthal
Title: Chief Financial Officer and Treasurer
BAKER NORTON
PHARMACEUTICALS, INC.
By: /s/Jane Hsiao
Name: Jane Hsiao
Title: Vice President
CONFIDENTIAL TREATMENT OF REDACTED PORTIONS HAS BEEN GRANTED BY THE SEC
